Study: Bristol’s apixaban effective among atrial fibrillation patients
NEW YORK — An investigational drug made by Bristol-Myers Squibb works better than aspirin in reducing the risk of complications in certain patients with heart rhythm problems, according to results of a late-stage clinical trial published in the New England Journal of Medicine.
Bristol said results of the phase-3 study comparing apixaban with aspirin showed that in patients with atrial fibrillation who were not suited to take the drug warfarin, apixaban was more effective than aspirin in reducing stroke and systemic embolism.
The investigational drug also was more effective than aspirin in reducing the composite of stroke, systemic embolism, heart attack and vascular death in atrial fibrillation patients.
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Avandia’s labeling information revised
PHILADELPHIA — GlaxoSmithKline has changed prescribing information on the labeling for one of its Type 2 diabetes drugs to reflect new restrictions on the drug’s use, the drug maker said.
GSK said it revised the labeling for Avandia (rosiglitazone) to take into account the risks of heart attacks and heart failure in patients taking the drug.
The FDA moved to restrict access to Avandia last year and required GSK to create a risk evaluation and mitigation strategy for the drug.
This label change is long overdue. Many patients lives could have been saved if this warning was placed when GSK knew of the problems related to MI's, CHF and Strokes. It is now GSK's responsibility to pay damages to those who have suffered from this medication.
Gilead resubmits HIV drug application to FDA
FOSTER CITY, Calif. — Gilead Sciences has refiled an approval application with the Food and Drug Administration for an HIV drug, the drug maker said.
Gilead said it had resubmitted its application for a single-tablet combination of Truvada (emtricitabine and tenofovir disoproxil fumarate) and Johnson & Johnson subsidiary Tibotec Pharmaceuticals’ investigational drug TMC278 (rilpivirine hydrochloride) to treat HIV-1 infection in adults.
Gilead had submitted its application for the drug in November 2010, but the FDA issued a “refuse to file” notification, requesting additional information on the analytical methodology and qualification data used to establish acceptable levels of recently identified degradants related to emtricitabine.
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